Identity
- Trade Name
- AC Swing EUDAMEDAcrobat FDA UDI
- Generic Name
- Medical monitor/light mount FDA UDI
- Device Name
- Leichtlast EUDAMED
- Model / Reference
- AC Swing EUDAMEDSwing FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04061591000004 EUDAMEDFDA UDI
- Basic UDI-DI
- 4061591000400QX EUDAMED
- Direct Marketing DI
- 04061591000004 EUDAMED
- FDA Product Code
- FQO FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Medical monitor/light mount FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4960 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Device sterilization/disinfection container, reusable
AC Swing by Ondal Medical Systems Gmbh — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4061591000400QX | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ondal Medical Systems GmbH
- EUDAMED SRN
- DE-MF-000000203
Sources (2)
- EUDAMED 3230eb7f-eeb2-4605-97d0-7e58dfdb00fc 61 fields · synced Jul 28, 2026
- FDA UDI cc263c60-9339-413d-b5a1-67e11a2d9b20 32 fields · synced May 29, 2026